[Federal Register Volume 88, Number 241 (Monday, December 18, 2023)]
[Notices]
[Page 87435]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-27662]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-5344]


Pharmacyclics LLC.; Withdrawal of Approval of Indications for 
Mantle Cell Lymphoma and Marginal Zone Lymphoma for IMBRUVICA 
(ibrutinib) Capsules and Tablets

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
that it is withdrawing approval of the indications for mantle cell 
lymphoma (MCL) and marginal zone lymphoma (MZL) for IMBRUVICA 
(ibrutinib) Capsules and Tablets approved, respectively, under new drug 
applications (NDAs) 205552 and 210563. These NDAs are held by 
Pharmacyclics LLC, 1000 Gateway Blvd., South San Francisco, CA 94080 
(Pharmacyclics). Pharmacyclics voluntarily requested that the Agency 
withdraw approval of these indications and waived its opportunity for a 
hearing.

DATES: Approval is withdrawn as of December 18, 2023.

FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137, <a href="/cdn-cgi/l/email-protection#12597b7f7077607e6b3c5e777a6074777e76527476733c7a7a613c757d64"><span class="__cf_email__" data-cfemail="72391b1f1017001e0b5c3e171a0014171e16321416135c1a1a015c151d04">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: On November 13, 2013, FDA approved NDA 
205552 for IMBRUVICA (ibrutinib) Capsules for the treatment of adult 
patients with MCL who have received at least one prior therapy (the MCL 
indication). On January 18, 2017, FDA approved a prior approval 
supplement for NDA 205552 for IMBRUVICA (ibrutinib) Capsules for the 
treatment of adult patients with MZL who require systemic therapy and 
have received at least one prior anti-CD20-based therapy (the MZL 
indication). On February 16, 2018, FDA approved NDA 210563 for 
IMBRUVICA (ibrutinib) Tablets, a new dosage form of IMBRUVICA 
(ibrutinib), for the MCL and MZL indications. FDA approved the MCL and 
MZL indications for both products under the Agency's accelerated 
approval regulations, 21 CFR part 314, subpart H. As a condition of 
accelerated approval of IMBRUVICA (ibrutinib) Capsules and Tablets for 
the MCL and MZL indications, the applicant was required to conduct 
postmarketing trials to verify the clinical benefit of ibrutinib for 
the MCL and MZL indications.
    On February 8, 2023, FDA met with Pharmacyclics to inform the 
applicant of the plans to convene the Oncologic Drugs Advisory 
Committee regarding the accelerated approvals for the MCL and MZL 
indications because the required postmarketing trials did not verify 
the clinical benefit of ibrutinib for these indications. On March 21, 
2023, FDA met with Pharmacyclics to discuss the applicant's request to 
voluntarily withdraw approval of the MCL and MZL indications for 
IMBRUVICA (ibrutinib) Capsules and Tablets. On April 6, 2023, 
Pharmacyclics submitted a letter requesting withdrawal of the MCL and 
MZL indications for IMBRUVICA (ibrutinib) Capsules and Tablets pursuant 
to Sec.  314.150(d) (21 CFR 314.150(d)) and waiving its opportunity for 
a hearing.
    Therefore, under Sec.  314.150(d), approvals of the MCL and MZL 
indications for IMBRUVICA (ibrutinib) Capsules and Tablets are 
withdrawn as of December 18, 2023. Withdrawal of approval of these 
indications does not affect any other approved indication for IMBRUVICA 
(ibrutinib) Capsules and Tablets.

    Dated: December 12, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-27662 Filed 12-15-23; 8:45 am]
BILLING CODE 4164-01-P


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